A Study to Evaluate the Antiviral Effect, Safety and Tole... | NCT04871113 | Trialant
NCT04871113
Sponsor
ViiV Healthcare
Status
Completed
Last Update Posted
Oct 15, 2024Actual
Enrollment
62Actual
Phase
Phase 2
Conditions
HIV Infections
Interventions
GSK3810109A
Dolutegravir+lamivudine SOC regimen
Countries
United States
Argentina
Brazil
Canada
Mexico
Peru
Protocol Section
Identification Module
NCT ID
NCT04871113
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
207959
Secondary IDs
Not provided
Brief Title
A Study to Evaluate the Antiviral Effect, Safety and Tolerability of GSK3810109A in Viremic Human Immunodeficiency Virus (HIV)-1 Infected Adults
Official Title
A Phase 2a Multicentre, Randomized, Open-Label, Two-Part Adaptive Design Study to Evaluate the Antiviral Effect, Safety and Tolerability of GSK3810109A, an HIV-1 Specific Broadly Neutralizing Human Monoclonal Antibody in Antiretroviral-naïve HIV-1-Infected Adults
Acronym
Not provided
Organization
ViiV HealthcareINDUSTRY
Status Module
Record Verification Date
Sep 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 22, 2021Actual
Primary Completion Date
Oct 27, 2022Actual
Completion Date
Sep 21, 2023Actual
First Submitted Date
Apr 28, 2021
First Submission Date that Met QC Criteria
Apr 28, 2021
First Posted Date
May 4, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Oct 27, 2023
Results First Submitted that Met QC Criteria
Oct 27, 2023
Results First Posted Date
Nov 18, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 18, 2024
Last Update Posted Date
Oct 15, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ViiV HealthcareINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is to evaluate antiviral activity, efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK3810109A in HIV-1 infected treatment naive adults. Participants will receive a single dose of GSK3810109A administered either intravenously (IV) or subcutaneously (SC). The study includes a screening phase, a randomized monotherapy phase and a standard of care follow-up phase.
Detailed Description
Not provided
Conditions Module
Conditions
HIV Infections
Keywords
Antiretroviral-naïve
Broadly neutralizing antibody
GSK3810109A
HIV
N6LS
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
62Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1:GSK3810109A 40milligram(mg)/kilogram intravenously (IV)
Experimental
Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.
Biological: GSK3810109A
Part 1: GSK3810109A 280 mg IV
Experimental
Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.
Biological: GSK3810109A
Part 2: GSK3810109A 700 mg IV
Experimental
Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
Biological: GSK3810109A
Part 2: GSK3810109A 70 mg IV
Experimental
Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
Biological: GSK3810109A
Part 2: GSK3810109A 700 mg subcutaneously (SC)
Experimental
Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GSK3810109A
Biological
GSK3810109A available as sterile aqueous solution.
Part 1: GSK3810109A 280 mg IV
Part 1:GSK3810109A 40milligram(mg)/kilogram intravenously (IV)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Maximum Decline From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Levels - Monotherapy Phase
Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. Maximum decline from baseline in plasma HIV-1 RNA were measured in participants. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.
Baseline (Day 1) and up to Day 84 or end of Monotherapy Phase
Number of Participants With Adverse Events (AEs) - Monotherapy Phase
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.
Up to Day 84 or end of Monotherapy Phase
Number of Participants With Worst-case Maximum Grade 2-4 Increase in Post-baseline Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Compared to the Baseline Values - Monotherapy Phase
Blood samples were collected for the analysis of ALT and AST parameters. The parameters ALT and AST were graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data of number of participants with 2-4 grade increase at worst-case post-baseline (maximum grade increase post-baseline) is presented. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.
Secondary Outcomes
Measure
Description
Time Frame
Area Under the Plasma Concentration-time Curve From Time Zero to the Day 14 (AUC [0-14]) of GSK3810109A - Monotherapy Phase
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3810109A.
Pre-dose (Day 1), 3 and 24 hours post-dose on day 1, days 3, 6, 9, 11, and 14
Maximum Observed Plasma Concentration (Cmax) of GSK3810109A - Monotherapy Phase
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
Participants must have HIV-1 infection within 45 days of the Screening Visit: Plasma HIV-1 RNA greater than or equal to (>=) 5000 copies/mL (c/mL).
Antiretroviral naïve: No Antiretroviral therapy (ARTs) (in combination or monotherapy) received after the diagnosis of HIV-1 infection.
Body weight >= 50 kg to less than or equal to (<=) 115 kg.
Male and/or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. All participants participating in the study should be counselled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g. male condom) and on the risk of HIV transmission to an uninfected partner; a. Participants who are female at birth are eligible to participate if at least one of the following conditions applies: Not Pregnant or breastfeeding and at least one of the following conditions applies: Is not a participant of childbearing potential (POCBP). OR Is a POCBP and using an acceptable contraceptive method during the intervention period (at a minimum until after the last dose of study intervention). The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A POCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) on Day 1, prior to the first dose of study intervention. If a urine test cannot be confirmed as negative (example [e.g.], an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
Participants with primary HIV infection, evidenced by acute retroviral syndrome (e.g., fever, malaise, fatigue, etc) and/or evidence of recent (within 3 months) documented viremia without antibody production and/or evidence of recent (within 3 months) documented seroconversion.
Participants who are pregnant, breastfeeding, plan to become pregnant or breastfeed during the study.
The participant has an underlying skin disease or disorder (example i.e. infection, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria) that would interfere with assessment of injection sites.
Known history of cirrhosis with or without viral hepatitis co-infection.
History of clinically relevant hepatitis within last 6 months.
Evidence of Hepatitis B virus (HBV) infection based on the results of testing at screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antigen antibody (anti-HBs) and HBV Deoxyribonucleic acid (DNA) as follows: Participants positive for HBsAg are excluded; Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded. Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and negative for HBV DNA are not excluded.
Participants with Hepatitis C co-infection.
Untreated syphilis infection (positive rapid plasma reagin [RPR] at screening) without documentation of treatment. Participants who are one month post completed treatment are eligible if recruitment is open.
Rescreening is allowed after treatment.
Prior receipt of licensed or investigational monoclonal antibody.
Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease except cutaneous Kaposi's sarcoma not requiring systemic therapy.
Known or suspected moderate or severe hepatic impairment (Class C as determined by Child-Pugh Classification) coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease at the discretion of the investigator.
Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the study medical monitor for inclusion of the participant prior to randomization.
Any pre-existing physical or mental condition which, in the opinion of the investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations, or which may compromise the safety of the participant.
Participants with substance abuse disorders or social restraints that the investigator considers to be possible deterrents to successful completion of the study.
Participants who in the investigator's judgment, pose a significant suicidality risk. Participants' history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk.
History of sensitivity to any of the study medications or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
Any condition which, in the opinion of the investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs, combination ART or render the participant unable to take oral medication.
Participants with a positive Corona Virus Disease 2019 (COVID-19) test at Screening. Participants with known COVID-19 positive contacts within the past 14 days, or with symptoms suggestive of active COVID-19 (fever, cough, myalgias, shortness of breath, loss of taste or smell), should be excluded. Participants who remain symptom-free for at least 14 days after a COVID-19 exposure are allowed.
Has received any HIV-1 immunotherapeutic vaccine or prophylactic vaccine.
Treatment with any of the following agents within 28 days of screening: radiation therapy; cytotoxic chemotherapeutic agents; any systemic immune suppressant;
Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP.
Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication.
Participant enrolled in a prior or concurrent clinical study that includes a drug intervention within the last 30 days.
Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant's inclusion in the study of an investigational compound.
Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening period to verify a result.
ALT >= 3 times the upper limit of normal (ULN).
Creatinine clearance of <50 mL/minute/1.73 meter^2) via Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method.
The participant has a tattoo or other dermatological condition overlying potential injection sites which may interfere with interpretation of injection site reactions or administration of GSK3810109A.
Leone PA, Ferro A, Rolle CP, Lupo S, McGowan J, Klein M, Cahn P, Benson P, Griesel R, Warwick-Sanders M, Sanchez M, D'Agostino R, Bettacchi C, Schneider S, Wannamaker P, Dorey D, Wilches V, Gartland M, Brown K, Gandhi Y, Donatti C, Losos J. VH3810109 Efficacy, Safety, Pharmacokinetics, and Incidence of Antidrug Antibodies in Adults With HIV-1 Naive to Antiretroviral Therapy: BANNER Study Results. J Infect Dis. 2025 Dec 20;232(6):e1022-e1032. doi: 10.1093/infdis/jiaf450.
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Access Criteria
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
Monotherapy phase had 2 parts (Part 1 and 2) where participants received GSK3810109A. All participants who completed monotherapy phase entered standard of care (SOC) follow-up phase to receive a regimen of dolutegravir + lamivudine.
Recruitment Details
62 unique participants were enrolled in the study including one participant that was re-screened. This re-screened participant signed two different informed consent forms, therefore this participant was counted as enrolling twice.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV)
Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.
FG001
Part 1: GSK3810109A 280 mg IV
Periods
Title
Milestones
Reasons Not Completed
Part1:Monotherapy Phase(up to Day 84)
Type
Comment
Milestone Data
STARTED
1 participant was randomized to Part 1: GSK3810109A 280 mg IV, but received GSK3810109A 40mg/kg IV intervention. Hence the participant was included in Part 1:GSK3810109A 40milligram(mg)/kilogram intravenously (IV) in the safety and pharmacokinetic set, and in Part 1: GSK3810109A 280 mg IV group in Full ANalysis Set, resulting in different sizes of these populations.
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jul 26, 2021
Oct 27, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
The is a sequential treatment, two-part study which will include a screening phase, a randomized monotherapy phase and a standard of care follow-up phase.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
This is an open-label study
Who Masked
Not provided
Biological: GSK3810109A
Standard of care (SOC) - GSK3810109A 40mg/kg IV
Experimental
Participants who completed the monotherapy phase of treatment of GSK3810109A 40mg/kg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
Biological: Dolutegravir+lamivudine SOC regimen
SOC - GSK3810109A 280 mg IV
Experimental
Participants who completed the monotherapy phase of treatment of GSK3810109A 280 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
Biological: Dolutegravir+lamivudine SOC regimen
SOC - GSK3810109A 700 mg IV
Experimental
Participants who completed the monotherapy phase of treatment of GSK3810109A 700 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
Biological: Dolutegravir+lamivudine SOC regimen
SOC - GSK3810109A 70 mg IV
Experimental
Participants who completed the monotherapy phase of treatment of GSK3810109A 70 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
Biological: Dolutegravir+lamivudine SOC regimen
SOC - GSK3810109A 700 mg SC
Experimental
Participants who completed the monotherapy phase of treatment of GSK3810109A 700 mg SC entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
Biological: Dolutegravir+lamivudine SOC regimen
Part 2: GSK3810109A 70 mg IV
Part 2: GSK3810109A 700 mg IV
Part 2: GSK3810109A 700 mg subcutaneously (SC)
Dolutegravir+lamivudine SOC regimen
Biological
Dolutegravir+lamivudine regimen administered in consistence with investigator input and local guidelines
SOC - GSK3810109A 280 mg IV
SOC - GSK3810109A 70 mg IV
SOC - GSK3810109A 700 mg IV
SOC - GSK3810109A 700 mg SC
Standard of care (SOC) - GSK3810109A 40mg/kg IV
Baseline (Day 1) and up to Day 84 or end of Monotherapy Phase
Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Findings - Monotherapy Phase
A 12-lead ECG were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT interval corrected using Fridericia's formula (QTcF) intervals. ECG findings were categorized as normal, abnormal clinically significant (CS) and abnormal not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of participants with abnormal (CS and NCS) ECG findings are presented. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.
Up to Day 84 or end of Monotherapy Phase
Number of Participants With Grade 2-4 Injection Site Reactions (ISR) - Monotherapy Phase
Number of participants with grade 2-4 injection site reactions are presented. The ISR were graded using the Division of Acquired immunodeficiency syndrome (DAIDS) criteria Version 2.1 where grades were defined based on numeric criteria as follows Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates more severe condition. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.
Up to Day 84 or end of Monotherapy Phase
Cmax is defined as maximum observed concentration of GSK3810109A.
Pre-dose (Day 1), 3 and 24 hours post-dose on day 1, days 3, 6, 9, 11, and 14
Time to Reach Maximum Observed Plasma Concentration (Tmax) of GSK3810109A - Monotherapy Phase
Tmax is defined as time to reach Cmax
Pre-dose (Day 1), 3 and 24 hours post-dose on day 1, days 3, 6, 9, 11, and 14
Plasma Concentration at Day 14 (C14) of GSK3810109A - Monotherapy Phase
Blood samples were collected at indicated time point for pharmacokinetic analysis of GSK3810109A.
At Day 14
Change From Baseline in Log10 Plasma HIV-1 RNA Relative to Cmax - Monotherapy Phase
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. Statistical analysis for relationship between PK parameter (Cmax) and PD measure (change from baseline in logarithm to base 10 (log10) values for plasma HIV-1 RNA) were explored using an Emax non-linear model. The model parameters estimated included: maximum response (Emax), PK parameter value that attains 50 percent (%) of the maximal effect (EC50) and residual variability (s2e). End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.
Baseline (Day 1) and up to Day 84 or end of Monotherapy Phase
Absolute Values of Cluster of Differentiation 4 Plus (CD4+) and CD8+ T Cell Counts - Monotherapy Phase
Blood samples were collected as prespecified. CD4+ and CD8+ T cell counts were assessed using flow cytometry. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.
From Day 1 (Baseline) and up to Day 84 or end of Monotherapy Phase
Absolute Values of CD4+ and CD8+ T Cell Counts - SOC Phase
Blood samples were collected as prespecified. CD4+ and CD8+ T cell counts were assessed using flow cytometry.
Up to Week 48 (SOC Phase)
Change From Baseline in CD4+ and CD8+ T Cell Counts - Monotherapy Phase
Blood samples were collected as prespecified. CD4+ and CD8+ T cell counts were assessed using flow cytometry. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.
Up to Day 84 or end of Monotherapy Phase (compared with baseline [Day 1])
Change From Baseline in CD4+ and CD8+ T Cell Counts - SOC Phase
Blood samples were collected as prespecified. CD4+ and CD8+ T cell counts were assessed using flow cytometry.
Up to Week 48 (SOC Phase)
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against GSK3810109A - Monotherapy Phase
Serum samples were collected to analyze the presence of ADAs against GSK3810109A using validated immunoassays. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.
At Day 1 and Day 84 or end of Monotherapy Phase
Number of Participants With Positive ADAs Against GSK3810109A - SOC Phase
Serum samples were collected to analyze the presence of ADAs against GSK3810109A using validated immunoassays.
At Week 48 (SOC Phase)
Titers of Positive ADAs Against GSK3810109A - Monotherapy Phase
Serum samples were collected to analyze the presence of ADAs against GSK3810109A using validated immunoassays. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.
At Day 84 or end of Monotherapy Phase
Titers of Positive ADAs Against GSK3810109A - SOC Phase
Serum samples were collected to analyze the presence of ADAs against GSK3810109A using validated immunoassays.
At Week 48 (SOC Phase)
Los Angeles
California
90027
United States
GSK Investigational Site
Los Angeles
California
90036
United States
GSK Investigational Site
Orlando
Florida
32803
United States
GSK Investigational Site
Berkley
Michigan
48072
United States
GSK Investigational Site
Manhasset
New York
11030
United States
GSK Investigational Site
Dallas
Texas
75246
United States
GSK Investigational Site
Buenos Aires
1023
Argentina
GSK Investigational Site
Buenos Aires
C1181ACH
Argentina
GSK Investigational Site
Buenos Aires
C1202ABB
Argentina
GSK Investigational Site
Buenos Aires
C1425AGC
Argentina
GSK Investigational Site
Ciudad Autonoma de Bueno
C1405CKC
Argentina
GSK Investigational Site
Mar del Plata
7600
Argentina
GSK Investigational Site
Rosario
S2000PBJ
Argentina
GSK Investigational Site
San Juan
5400
Argentina
GSK Investigational Site
Rio de Janeiro
21045-900
Brazil
GSK Investigational Site
São Paulo
05403-010
Brazil
GSK Investigational Site
Ottawa
Ontario
K1H 8L6
Canada
GSK Investigational Site
Toronto
Ontario
M5G 2N2
Canada
GSK Investigational Site
Montreal
Quebec
H4A 3J1
Canada
GSK Investigational Site
Regina
Saskatchewan
S4P 0W5
Canada
GSK Investigational Site
Mérida
97000
Mexico
GSK Investigational Site
Monterrey
66278
Mexico
GSK Investigational Site
Lima
Lima 4
Peru
Derived
Leone PA, Losos J, Wannamaker P, D'Agostino R, Warwick-Sanders M, Ghita GL, Wilches V, Donatti C, Brown K, Gandhi Y. VH3810109 (N6LS) broadly neutralizing antibody safety, pharmacokinetics, and anti-drug antibody incidence in adults without HIV: phase 1 SPAN study results. Antimicrob Agents Chemother. 2025 Sep 3;69(9):e0025825. doi: 10.1128/aac.00258-25. Epub 2025 Jul 23.
Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.
FG002
Part 2: GSK3810109A 700 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
FG003
Part 2: GSK3810109A 70 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
FG004
Part 2: GSK3810109A 700 mg Subcutaneously (SC)
Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
FG005
SOC - GSK3810109A 40mg/kg IV
Participants who completed the monotherapy phase of treatment of GSK3810109A 40mg/kg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
FG006
SOC - GSK3810109A 280 mg IV
Participants who completed the monotherapy phase of treatment of GSK3810109A 280 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
FG007
SOC - GSK3810109A 700 mg IV
Participants who completed the monotherapy phase of treatment of GSK3810109A 700 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
FG008
SOC - GSK3810109A 70 mg IV
Participants who completed the monotherapy phase of treatment of GSK3810109A 70 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
FG009
SOC - GSK3810109A 700 mg SC
Participants who completed the monotherapy phase of treatment of GSK3810109A 700 mg SC entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
FG0008 subjects
FG0016 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0008 subjects
FG0016 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Part2:Monotherapy Phase(up to Day 84)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG00216 subjectsPart 2 enrolled new participants and the dosing for part 2 was based on the part 1 data.
FG00316 subjectsPart 2 enrolled new participants and the dosing for part 2 was based on the part 1 data.
FG00416 subjectsPart 2 enrolled new participants and the dosing for part 2 was based on the part 1 data.
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG00216 subjects
FG00316 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
SOC Follow-up (SOC Day 1 to 48 Weeks)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0058 subjectsParticipants are transferred from GSK3810109A 40 mg/kg IV arm.
FG0066 subjectsParticipants are transferred from GSK3810109A 280 mg IV arm.
FG00716 subjectsParticipants are transferred from GSK3810109A 700 mg IV arm.
FG00816 subjectsParticipants are transferred from GSK3810109A 70 mg IV arm.
FG00916 subjectsParticipants are transferred from GSK3810109A 700 mg SC arm.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV)
Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.
BG001
Part 1: GSK3810109A 280 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.
BG002
Part 2: GSK3810109A 700 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
BG003
Part 2: GSK3810109A 70 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
BG004
Part 2: GSK3810109A 700 mg Subcutaneously (SC)
Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0008
BG0016
BG00216
BG00316
BG00416
BG00562
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
YEARS
Title
Denominators
Categories
Title
Measurements
BG00034.3± 9.39
BG00134.0± 14.83
BG00231.2± 10.46
BG003
Sex/Gender, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0011
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Maximum Decline From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Levels - Monotherapy Phase
Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. Maximum decline from baseline in plasma HIV-1 RNA were measured in participants. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.
The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.
Posted
Median
Full Range
Copies per milliliter (copies/mL)
Baseline (Day 1) and up to Day 84 or end of Monotherapy Phase
ID
Title
Description
OG000
Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV)
Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.
OG001
Part 1: GSK3810109A 280 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.
OG002
Part 2: GSK3810109A 700 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
OG003
Part 2: GSK3810109A 70 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
OG004
Part 2: GSK3810109A 700 mg Subcutaneously (SC)
Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Units
Counts
Participants
OG0008
OG0016
OG00216
OG003
Title
Denominators
Categories
Baseline (Day 1)
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG00216
ParticipantsOG003
Primary
Number of Participants With Adverse Events (AEs) - Monotherapy Phase
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.
The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.
Posted
Count of Participants
Participants
Up to Day 84 or end of Monotherapy Phase
ID
Title
Description
OG000
Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV)
Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.
OG001
Part 1: GSK3810109A 280 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.
OG002
Part 2: GSK3810109A 700 mg IV
Primary
Number of Participants With Worst-case Maximum Grade 2-4 Increase in Post-baseline Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Compared to the Baseline Values - Monotherapy Phase
Blood samples were collected for the analysis of ALT and AST parameters. The parameters ALT and AST were graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data of number of participants with 2-4 grade increase at worst-case post-baseline (maximum grade increase post-baseline) is presented. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.
The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.
Posted
Count of Participants
Participants
Baseline (Day 1) and up to Day 84 or end of Monotherapy Phase
ID
Title
Description
OG000
Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV)
Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.
Primary
Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Findings - Monotherapy Phase
A 12-lead ECG were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT interval corrected using Fridericia's formula (QTcF) intervals. ECG findings were categorized as normal, abnormal clinically significant (CS) and abnormal not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of participants with abnormal (CS and NCS) ECG findings are presented. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.
The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.
Posted
Count of Participants
Participants
Up to Day 84 or end of Monotherapy Phase
ID
Title
Description
OG000
Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV)
Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.
OG001
Part 1: GSK3810109A 280 mg IV
Primary
Number of Participants With Grade 2-4 Injection Site Reactions (ISR) - Monotherapy Phase
Number of participants with grade 2-4 injection site reactions are presented. The ISR were graded using the Division of Acquired immunodeficiency syndrome (DAIDS) criteria Version 2.1 where grades were defined based on numeric criteria as follows Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates more severe condition. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.
The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.
Posted
Count of Participants
Participants
Up to Day 84 or end of Monotherapy Phase
ID
Title
Description
OG000
Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV)
Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.
OG001
Part 1: GSK3810109A 280 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.
Secondary
Area Under the Plasma Concentration-time Curve From Time Zero to the Day 14 (AUC [0-14]) of GSK3810109A - Monotherapy Phase
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3810109A.
Analysis was performed on the Pharmacokinetic (PK) population, which included all participants in the Safety population who had at least 1 non-missing PK assessment (Non-quantifiable [NQ] values with the actual dose and PK sampling time will be considered as non-missing values).
Posted
Geometric Mean
Geometric Coefficient of Variation
Day *microgram/millilitre (day*ug/mL)
Pre-dose (Day 1), 3 and 24 hours post-dose on day 1, days 3, 6, 9, 11, and 14
ID
Title
Description
OG000
Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV)
Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.
OG001
Part 1: GSK3810109A 280 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.
OG002
Part 2: GSK3810109A 700 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
Secondary
Maximum Observed Plasma Concentration (Cmax) of GSK3810109A - Monotherapy Phase
Cmax is defined as maximum observed concentration of GSK3810109A.
Analysis was performed on the PK population, which included all participants in the Safety population who had at least 1 non-missing PK assessment (NQ values with the actual dose and PK sampling time will be considered as non-missing values).
Posted
Mean
Standard Deviation
Microgram/millilitre (μg/mL)
Pre-dose (Day 1), 3 and 24 hours post-dose on day 1, days 3, 6, 9, 11, and 14
ID
Title
Description
OG000
Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV)
Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.
OG001
Part 1: GSK3810109A 280 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.
OG002
Part 2: GSK3810109A 700 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
Secondary
Time to Reach Maximum Observed Plasma Concentration (Tmax) of GSK3810109A - Monotherapy Phase
Tmax is defined as time to reach Cmax
Analysis was performed on the PK population, which included all participants in the Safety population who had at least 1 non-missing PK assessment (NQ values with the actual dose and PK sampling time will be considered as non-missing values).
Posted
Median
Full Range
Days
Pre-dose (Day 1), 3 and 24 hours post-dose on day 1, days 3, 6, 9, 11, and 14
ID
Title
Description
OG000
Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV)
Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.
OG001
Part 1: GSK3810109A 280 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.
OG002
Part 2: GSK3810109A 700 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
Secondary
Plasma Concentration at Day 14 (C14) of GSK3810109A - Monotherapy Phase
Blood samples were collected at indicated time point for pharmacokinetic analysis of GSK3810109A.
Analysis was performed on the PK population, which included all participants in the Safety population who had at least 1 non-missing PK assessment (NQ values with the actual dose and PK sampling time will be considered as non-missing values).
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
At Day 14
ID
Title
Description
OG000
Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV)
Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.
OG001
Part 1: GSK3810109A 280 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.
OG002
Part 2: GSK3810109A 700 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
Secondary
Change From Baseline in Log10 Plasma HIV-1 RNA Relative to Cmax - Monotherapy Phase
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. Statistical analysis for relationship between PK parameter (Cmax) and PD measure (change from baseline in logarithm to base 10 (log10) values for plasma HIV-1 RNA) were explored using an Emax non-linear model. The model parameters estimated included: maximum response (Emax), PK parameter value that attains 50 percent (%) of the maximal effect (EC50) and residual variability (s2e). End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.
The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed. Only participants in the IV dosing group with data available at the specified time points were analyzed.
Posted
Mean
Standard Deviation
Log10 copies per milliliter (copies/mL)
Baseline (Day 1) and up to Day 84 or end of Monotherapy Phase
ID
Title
Description
OG000
Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV)
Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.
Secondary
Absolute Values of Cluster of Differentiation 4 Plus (CD4+) and CD8+ T Cell Counts - Monotherapy Phase
Blood samples were collected as prespecified. CD4+ and CD8+ T cell counts were assessed using flow cytometry. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.
The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.
Posted
Mean
Standard Deviation
Cells per cubic milimeter
From Day 1 (Baseline) and up to Day 84 or end of Monotherapy Phase
ID
Title
Description
OG000
Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV)
Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.
OG001
Part 1: GSK3810109A 280 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.
OG002
Part 2: GSK3810109A 700 mg IV
Secondary
Absolute Values of CD4+ and CD8+ T Cell Counts - SOC Phase
Blood samples were collected as prespecified. CD4+ and CD8+ T cell counts were assessed using flow cytometry.
The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.
Posted
Mean
Standard Deviation
Cells per cubic milimeter
Up to Week 48 (SOC Phase)
ID
Title
Description
OG000
SOC - GSK3810109A 40mg/kg IV
Participants who completed the monotherapy phase of treatment of GSK3810109A 40mg/kg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
OG001
SOC - GSK3810109A 280 mg IV
Participants who completed the monotherapy phase of treatment of GSK3810109A 280 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
OG002
SOC - GSK3810109A 700 mg IV
Participants who completed the monotherapy phase of treatment of GSK3810109A 700 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
Secondary
Change From Baseline in CD4+ and CD8+ T Cell Counts - Monotherapy Phase
Blood samples were collected as prespecified. CD4+ and CD8+ T cell counts were assessed using flow cytometry. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.
The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.
Posted
Mean
Standard Deviation
Cells per cubic milimeter
Up to Day 84 or end of Monotherapy Phase (compared with baseline [Day 1])
ID
Title
Description
OG000
Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV)
Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.
OG001
Part 1: GSK3810109A 280 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.
OG002
Part 2: GSK3810109A 700 mg IV
Secondary
Change From Baseline in CD4+ and CD8+ T Cell Counts - SOC Phase
Blood samples were collected as prespecified. CD4+ and CD8+ T cell counts were assessed using flow cytometry.
The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.
Posted
Mean
Standard Deviation
Cells per cubic milimeter
Up to Week 48 (SOC Phase)
ID
Title
Description
OG000
SOC - GSK3810109A 40mg/kg IV
Participants who completed the monotherapy phase of treatment of GSK3810109A 40mg/kg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
OG001
SOC - GSK3810109A 280 mg IV
Participants who completed the monotherapy phase of treatment of GSK3810109A 280 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
OG002
SOC - GSK3810109A 700 mg IV
Participants who completed the monotherapy phase of treatment of GSK3810109A 700 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
Secondary
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against GSK3810109A - Monotherapy Phase
Serum samples were collected to analyze the presence of ADAs against GSK3810109A using validated immunoassays. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.
The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.
Posted
Count of Participants
Participants
At Day 1 and Day 84 or end of Monotherapy Phase
ID
Title
Description
OG000
Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV)
Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.
OG001
Part 1: GSK3810109A 280 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.
OG002
Part 2: GSK3810109A 700 mg IV
Secondary
Number of Participants With Positive ADAs Against GSK3810109A - SOC Phase
Serum samples were collected to analyze the presence of ADAs against GSK3810109A using validated immunoassays.
The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.
Posted
Count of Participants
Participants
At Week 48 (SOC Phase)
ID
Title
Description
OG000
SOC - GSK3810109A 40mg/kg IV
Participants who completed the monotherapy phase of treatment of GSK3810109A 40mg/kg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
OG001
SOC - GSK3810109A 280 mg IV
Participants who completed the monotherapy phase of treatment of GSK3810109A 280 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
OG002
SOC - GSK3810109A 700 mg IV
Participants who completed the monotherapy phase of treatment of GSK3810109A 700 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
Secondary
Titers of Positive ADAs Against GSK3810109A - Monotherapy Phase
Serum samples were collected to analyze the presence of ADAs against GSK3810109A using validated immunoassays. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.
The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.
Posted
Median
Full Range
Titers
At Day 84 or end of Monotherapy Phase
ID
Title
Description
OG000
Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV)
Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.
OG001
Part 1: GSK3810109A 280 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.
OG002
Part 2: GSK3810109A 700 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
Secondary
Titers of Positive ADAs Against GSK3810109A - SOC Phase
Serum samples were collected to analyze the presence of ADAs against GSK3810109A using validated immunoassays.
The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.
Posted
Median
Full Range
Titers
At Week 48 (SOC Phase)
ID
Title
Description
OG000
SOC - GSK3810109A 40mg/kg IV
Participants who completed the monotherapy phase of treatment of GSK3810109A 40mg/kg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
OG001
SOC - GSK3810109A 280 mg IV
Participants who completed the monotherapy phase of treatment of GSK3810109A 280 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
OG002
SOC - GSK3810109A 700 mg IV
Participants who completed the monotherapy phase of treatment of GSK3810109A 700 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
Time Frame
All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups).
Description
Safety population included all participants who received at least one dose of study treatment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV)
Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.
0
8
0
8
7
8
EG001
Part 1: GSK3810109A 280 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.
0
6
0
6
4
6
EG002
Part 2: GSK3810109A 700 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
0
16
0
16
9
16
EG003
Part 2: GSK3810109A 70 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
0
16
0
16
8
16
EG004
Part 2: GSK3810109A 700 mg Subcutaneously (SC)
Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
0
16
0
16
11
16
EG005
SOC - GSK3810109A 40mg/kg IV
Participants who completed the monotherapy phase of treatment of GSK3810109A 40mg/kg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
0
8
1
8
8
8
EG006
SOC - GSK3810109A 280 mg IV
Participants who completed the monotherapy phase of treatment of GSK3810109A 280 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
0
6
0
6
3
6
EG007
SOC - GSK3810109A 700 mg IV
Participants who completed the monotherapy phase of treatment of GSK3810109A 700 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
0
16
3
16
12
16
EG008
SOC - GSK3810109A 70 mg IV
Participants who completed the monotherapy phase of treatment of GSK3810109A 70 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
0
16
2
16
13
16
EG009
SOC - GSK3810109A 700 mg SC
Participants who completed the monotherapy phase of treatment of GSK3810109A 700 mg SC entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
0
16
4
16
14
16
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Suicide attempt
Psychiatric disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG0030 events0 affected16 at risk
EG0040 events0 affected16 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected16 at risk
EG0080 events0 affected16 at risk
EG0091 events1 affected16 at risk
Appendicitis
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Scrotal abscess
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Human rhinovirus test positive
Investigations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukopenia
Blood and lymphatic system disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG0030 events0 affected16 at risk
EG0040 events0 affected16 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected16 at risk
EG0081 events1 affected16 at risk
EG0090 events0 affected16 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v25.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected16 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA v25.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Hyperaesthesia teeth
Gastrointestinal disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected16 at risk
EG003
Tooth impacted
Gastrointestinal disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Application site pain
General disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Asthenia
General disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Chills
General disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Fatigue
General disorders
MedDRA v25.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected16 at risk
EG003
Influenza like illness
General disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Infusion site bruising
General disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Infusion site erythema
General disorders
MedDRA v25.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Infusion site pain
General disorders
MedDRA v25.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected16 at risk
EG003
Injection site bruising
General disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Injection site discolouration
General disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Injection site pain
General disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Injection site pruritus
General disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Vessel puncture site bruise
General disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Anal abscess
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Anorectal human papilloma virus infection
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected16 at risk
EG003
COVID-19
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Chlamydial infection
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Hordeolum
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected16 at risk
EG003
Influenza
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected6 at risk
EG0022 events2 affected16 at risk
EG003
Monkeypox
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Oropharyngeal gonococcal infection
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Proctitis gonococcal
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Rhinitis
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected16 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Syphilis
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected16 at risk
EG003
Viral sinusitis
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0023 events1 affected16 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA v25.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected16 at risk
EG003
Creatinine renal clearance decreased
Investigations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Lipase increased
Investigations
MedDRA v25.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA v25.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Plantar fascial fibromatosis
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected16 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v25.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Headache
Nervous system disorders
MedDRA v25.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected16 at risk
EG003
Migraine
Nervous system disorders
MedDRA v25.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Somnolence
Nervous system disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Attention deficit hyperactivity disorder
Psychiatric disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Bipolar disorder
Psychiatric disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Depression
Psychiatric disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Hallucination, auditory
Psychiatric disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected16 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected16 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected16 at risk
EG003
Urine abnormality
Renal and urinary disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Cervical dysplasia
Reproductive system and breast disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected16 at risk
EG003
Tonsillar hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected16 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected16 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v25.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Hot flush
Vascular disorders
MedDRA v25.1
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Hypertension
Vascular disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Oral herpes
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Dengue fever
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Helminthic infection
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Papilloma viral infection
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Scrotal abscess
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Secondary syphilis
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Sepsis
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Urethritis gonococcal
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Viral infection
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Vulvovaginitis
Infections and infestations
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Peripheral swelling
General disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Pyrexia
General disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Affect lability
Psychiatric disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Anxiety disorder
Psychiatric disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Bone swelling
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Myokymia
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Chemical burn of gastrointestinal tract
Injury, poisoning and procedural complications
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Exposure to communicable disease
Injury, poisoning and procedural complications
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Glycosuria
Renal and urinary disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Catarrh
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Internal haemorrhage
Vascular disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Anogenital warts
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Scrotal ulcer
Reproductive system and breast disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Eye pain
Eye disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA v25.1
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected16 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Maximum decline from baseline (up to Day 84/end of Monotherapy Phase)
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG00215
ParticipantsOG00316
ParticipantsOG00416
Title
Measurements
OG000-12014.5(-171577 to -1312)
OG001-26826.5(-103583 to -5899)
OG002-25966.0(-107218 to -6944)
OG003
Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
OG003
Part 2: GSK3810109A 70 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
OG004
Part 2: GSK3810109A 700 mg Subcutaneously (SC)
Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Units
Counts
Participants
OG0008
OG0016
OG00216
OG00316
OG00416
Title
Denominators
Categories
Title
Measurements
OG0007
OG0014
OG0029
OG0038
OG00411
OG001
Part 1: GSK3810109A 280 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.
OG002
Part 2: GSK3810109A 700 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
OG003
Part 2: GSK3810109A 70 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
OG004
Part 2: GSK3810109A 700 mg Subcutaneously (SC)
Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Units
Counts
Participants
OG0008
OG0016
OG00216
OG00316
OG00416
Title
Denominators
Categories
ALT, Baseline, Grade 0
Title
Measurements
OG0008
OG0016
OG00215
OG00312
OG00415
ALT, Baseline, Grade 1
Title
Measurements
OG0000
OG0010
OG0021
OG003
ALT, Baseline, Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT, Baseline, Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT, Baseline, Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT, Worst Case Post-Baseline, Increase to Grades 2 to 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT, Worst Case Post-Baseline, Increase to Grades 3 to 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST, Baseline, Grade 0
Title
Measurements
OG0008
OG0016
OG00215
OG003
AST, Baseline, Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST, Baseline, Grade 2
Title
Measurements
OG0000
OG0010
OG0021
OG003
AST, Baseline, Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST, Baseline, Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST, Worst Case Post-Baseline, Increase to Grades 2 to 4
Title
Measurements
OG0001
OG0010
OG0021
OG003
AST, Worst Case Post-Baseline, Increase to Grades 3 to 4
Title
Measurements
OG0001
OG0010
OG0021
OG003
Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.
OG002
Part 2: GSK3810109A 700 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
OG003
Part 2: GSK3810109A 70 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
OG004
Part 2: GSK3810109A 700 mg Subcutaneously (SC)
Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Units
Counts
Participants
OG0008
OG0016
OG00216
OG00316
OG00416
Title
Denominators
Categories
Abnormal - Clinically Significant
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
Abnormal - Not Clinically Significant
Title
Measurements
OG0003
OG0012
OG0023
OG003
OG002
Part 2: GSK3810109A 700 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
OG003
Part 2: GSK3810109A 70 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
OG004
Part 2: GSK3810109A 700 mg Subcutaneously (SC)
Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Units
Counts
Participants
OG0008
OG0016
OG00216
OG00316
OG00416
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG003
Part 2: GSK3810109A 70 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
OG004
Part 2: GSK3810109A 700 mg Subcutaneously (SC)
Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Units
Counts
Participants
OG0008
OG0016
OG00214
OG00316
OG00416
Title
Denominators
Categories
Title
Measurements
OG0005346.3194± 29.6508
OG001690.8944± 53.2785
OG0021181.1688± 24.4990
OG003212.6213± 79.1478
OG004493.0579± 55.0909
OG003
Part 2: GSK3810109A 70 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
OG004
Part 2: GSK3810109A 700 mg Subcutaneously (SC)
Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Units
Counts
Participants
OG0008
OG0016
OG00216
OG00316
OG00416
Title
Denominators
Categories
Title
Measurements
OG0001131.5000± 329.91168
OG001131.1500± 86.65425
OG002243.0625± 57.37301
OG00342.7688± 54.32691
OG00445.0938± 20.48930
OG003
Part 2: GSK3810109A 70 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
OG004
Part 2: GSK3810109A 700 mg Subcutaneously (SC)
Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Units
Counts
Participants
OG0008
OG0016
OG00216
OG00316
OG00416
Title
Denominators
Categories
Title
Measurements
OG0000.0385(0.024 to 0.125)
OG0010.1233(0.026 to 0.149)
OG0020.0340(0.021 to 0.128)
OG0030.0278(0.003 to 0.994)
OG0045.9177(1.884 to 14.966)
OG003
Part 2: GSK3810109A 70 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
OG004
Part 2: GSK3810109A 700 mg Subcutaneously (SC)
Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Units
Counts
Participants
OG0008
OG0016
OG00211
OG00311
OG00415
Title
Denominators
Categories
Title
Measurements
OG000221.45± 23.76
OG00127.49± 49.24
OG00255.30± 22.08
OG0037.98± 89.70
OG00429.52± 54.30
OG001
Part 1: GSK3810109A 280 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.
OG002
Part 2: GSK3810109A 700 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
OG003
Part 2: GSK3810109A 70 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
Units
Counts
Participants
OG0008
OG0016
OG00216
OG00316
Title
Denominators
Categories
Baseline (Day 1)
Title
Measurements
OG0004.139± 0.6433
OG0014.493± 0.4800
OG0024.465± 0.3594
OG0034.582± 0.6144
Change from baseline (up to Day 84 or end of Monotherapy Phase)
Title
Measurements
OG0000.091± 0.2359
OG001-0.357± 0.4191
OG002-0.110± 0.1940
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
Emax
-1.848
2-Sided
95
-2.225
-1.472
Emax is defined as maximum response.
Other
OG000
OG001
OG002
OG003
EC50
68.578
2-Sided
95
15.866
121.290
EC50 is defined as the dose (in mg) that attains the 50% of the maximal effect.
Other
OG000
OG001
OG002
OG003
s2e
0.257
2-Sided
95
0.145
0.368
e is defined as random error assumed to be normally distributed with mean zero and constant variance (s2).
Other
Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
OG003
Part 2: GSK3810109A 70 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
OG004
Part 2: GSK3810109A 700 mg Subcutaneously (SC)
Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Units
Counts
Participants
OG0008
OG0016
OG00216
OG00316
OG00416
Title
Denominators
Categories
CD4+, Baseline (Day 1 (Monotherapy Phase)
Title
Measurements
OG000360.5± 166.54
OG001412.8± 120.85
OG002427.3± 187.22
OG003467.3± 194.45
OG004476.7± 180.28
CD4+, Day 84/end of Monotherapy Phase
Title
Measurements
OG000392.3± 196.16
OG001443.0± 155.17
OG002424.0± 171.33
OG003
CD8+, Baseline (Day 1 (Monotherapy Phase)
Title
Measurements
OG000852.0± 441.83
OG001884.5± 389.42
OG002781.8± 303.75
OG003
CD8+, Day 84/End of Monotherapy Phase
Title
Measurements
OG000837.9± 482.68
OG001869.8± 376.86
OG002744.0± 267.73
OG003
OG003
SOC - GSK3810109A 70 mg IV
Participants who completed the monotherapy phase of treatment of GSK3810109A 70 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
OG004
SOC - GSK3810109A 700 mg SC
Participants who completed the monotherapy phase of treatment of GSK3810109A 700 mg SC entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
Units
Counts
Participants
OG0008
OG0016
OG00216
OG00316
OG00416
Title
Denominators
Categories
CD4+, Week 48 (SOC Phase)
Title
Measurements
OG000500.5± 211.17
OG001601.0± 44.74
OG002580.9± 165.29
OG003671.3± 180.25
OG004723.9± 300.24
CD8+, Week 48 (SOC Phase)
Title
Measurements
OG000685.9± 308.89
OG001738.4± 213.22
OG002684.9± 286.60
OG003
Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
OG003
Part 2: GSK3810109A 70 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
OG004
Part 2: GSK3810109A 700 mg Subcutaneously (SC)
Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Units
Counts
Participants
OG0008
OG0016
OG00216
OG00316
OG00416
Title
Denominators
Categories
CD4+, Baseline (Day 1 (Monotherapy Phase)
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG00216
ParticipantsOG00316
ParticipantsOG00416
Title
Measurements
OG000360.5± 166.54
OG001412.8± 120.85
OG002427.3± 187.22
OG003
CD4+, Day 84/end of Monotherapy Phase (compared with baseline)
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG00216
ParticipantsOG003
CD8+, Baseline (Day 1 (Monotherapy Phase)
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG00216
ParticipantsOG00316
CD8+, Day 84/end of Monotherapy Phase (compared with baseline)
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG00216
ParticipantsOG003
OG003
SOC - GSK3810109A 70 mg IV
Participants who completed the monotherapy phase of treatment of GSK3810109A 70 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
OG004
SOC - GSK3810109A 700 mg SC
Participants who completed the monotherapy phase of treatment of GSK3810109A 700 mg SC entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
Units
Counts
Participants
OG0008
OG0016
OG00216
OG00316
OG00416
Title
Denominators
Categories
CD4+, Baseline (Day 1 (Monotherapy Phase)
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG00216
ParticipantsOG00316
ParticipantsOG00416
Title
Measurements
OG000360.5± 166.54
OG001412.8± 120.85
OG002427.3± 187.22
OG003
CD4+, Week 48 of SOC Phase (compared with baseline)
ParticipantsOG0008
ParticipantsOG0015
ParticipantsOG00214
ParticipantsOG003
CD8+, Baseline (Day 1 (Monotherapy Phase)
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG00216
ParticipantsOG00316
CD8+, Week 48 of SOC Phase (compared with baseline)
ParticipantsOG0008
ParticipantsOG0015
ParticipantsOG00214
ParticipantsOG003
Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
OG003
Part 2: GSK3810109A 70 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
OG004
Part 2: GSK3810109A 700 mg Subcutaneously (SC)
Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Units
Counts
Participants
OG0008
OG0016
OG00216
OG00316
OG00416
Title
Denominators
Categories
Baseline (Day 1)
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG00215
ParticipantsOG00316
ParticipantsOG00416
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 84/End of Monotherapy Phase
ParticipantsOG0008
ParticipantsOG0015
ParticipantsOG00216
ParticipantsOG00316
OG003
SOC - GSK3810109A 70 mg IV
Participants who completed the monotherapy phase of treatment of GSK3810109A 70 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
OG004
SOC - GSK3810109A 700 mg SC
Participants who completed the monotherapy phase of treatment of GSK3810109A 700 mg SC entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
Units
Counts
Participants
OG0008
OG0015
OG00214
OG00316
OG00416
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG0032
OG0040
OG003
Part 2: GSK3810109A 70 mg IV
Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
OG004
Part 2: GSK3810109A 700 mg Subcutaneously (SC)
Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Units
Counts
Participants
OG0001
OG0012
OG0020
OG0033
OG0040
Title
Denominators
Categories
Title
Measurements
OG00040(40 to 40)
OG00160(40 to 80)
OG00380(40 to 640)
OG003
SOC - GSK3810109A 70 mg IV
Participants who completed the monotherapy phase of treatment of GSK3810109A 70 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
OG004
SOC - GSK3810109A 700 mg SC
Participants who completed the monotherapy phase of treatment of GSK3810109A 700 mg SC entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.